March 31, 2023 — According to statement issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because a communication loss between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA may cause an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, one or both of the PCBAs will need to be replaced for the device to work again.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
- Product Models:
- Distribution Dates: March 6, 2012 to January 13, 2023
- Devices Recalled in the U.S.: Estimated 4,502
- Date Initiated by Firm: January 9, 2023
The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in health care facilities.
Reason for Recall
Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because a communication loss between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA may cause an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, one or both of the PCBAs will need to be replaced for the device to work again.
An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage and/or death, especially for people who are critically ill and most likely to receive therapy using these devices.
Datascope/Getinge reported 42 complaints about PCBA communication failures resulting in unexpected shutdowns. There are no reports of any injuries or deaths related to this issue.
Who May be Affected
- People who receive circulatory support using a CardioSave Hybrid or Rescue IABP
- Health care personnel providing care that includes the CardioSave Hybrid or Rescue IABP
What to Do
On February 7, 2023, Datascope/Getinge sent customers an Urgent Medical Device Correction letter. The letter offered the following clinical guidelines and user actions related to the PCBA communication failure as part of a list of several notifications.
PCBA Communication Failure Clinical User Actions
- Use another IABP to continue therapy if an unexpected shutdown occurs.
- If the device remains inoperable after a shutdown:
- Remove it from patient care.
- Contact a service representative to identify the cause and take necessary actions.
PCBA Communication Failure User Actions
- Examine inventory immediately to identify any Cardiosave Hybrid and/or Rescue IABPs.
- Ensure that all Cardiosave Intra-Aortic Balloon Pump users are aware of this notice and actions to perform.
- Complete and sign the MEDICAL DEVICE CORRECTION – RESPONSE form included with the letter to acknowledge receipt of notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-877-660-5841.
- Distributors should forward the letter to any customers who received affected products.
Datascope/Getinge has developed a software correction to address this issue, and a service representative will contact customers to schedule installation of the software when it is available.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.